S.L. 458.33 Art. 4Blister packs.

(a) The particulars laid down under regulation 3 shall appear on immediate packagings other than those referred to in paragraphs (b) and (c) hereof.

(b) At least the following particulars shall appear on the immediate packaging when this takes the form of a blister pack which is then placed in an outer packaging which complies with the provisions laid down in regulations 3 and 9:

(i) the name of the medicinal product as laid down under regulation 3(a);

(ii) the name of the holder of the marketing authorisation;

(iii) the expiry date;

(iv) the batch number.

(c) In the case of small immediate packaging units on which the particulars laid down under regulations 3 and 9 cannot be displayed, the following particulars at least shall appear:

(i) the name of the medicinal product as laid down in regulation 3(a), and, if necessary, the route of administration,

(ii) the method of administration;

(iii) the expiry date;

(iv) the batch number;

(v) the contents by weight, by volume or by unit: Provided that where the immediate packaging of the medicinal product includes the name of the product, the active substance or substances, pharmaceutical form and strength, in the Roman alphabet, all or any of the particulars in paragraphs (b) and (c) of this regulation, unless already included in the outer packaging may alternatively be included and accessed by means of the electronic package leaflet: Provided further that this electronic package leaflet may only be used for medicinal products procured for the national health service.